PROGNOSIS

Clinical Epidemiology and Evidence-based Medicine Unit FKUI RSCM

Introduction - Prognosis
important phase of a disease progression of a disease. Patients, doctors, insurances concern Prognosis: the prediction of the future course of events following the onset of disease. can include death, complications, remission/recurrence, morbidity, disability and social or occupational function.

Introduction - Prognosis
Possible outcomes of a disease and the frequency with which they can be expected to occur.
Natural history: the evolution of disease without medical intervention. Clinical course: the evolution of disease in response to medical intervention.

Natural History Studies

Degree to which natural history can be studied depends on the medical system (Scandinavia) and the type of disease (rare, high risk). The natural history of some diseases can be studied because:
remain unrecognized (i.e., asymptomatic) e.g., anemia, hypertension. considered normal discomforts e.g., arthritis, mild depression.

Natural History Studies

Natural history studies permit the development of rational strategies for:
early detection of disease
e.g., Invasive Cervical CA.

treatment of disease
e.g.Ptyriasis versicolor Diabetes

Prognosis
Patients at risk of target event Prognostic factor Time

Suffer target outcome

Do not suffer target outcome

? ?

A. ARE THE RESULTS OF THIS PROGNOSIS STUDY VALID?

1. Was a defined, representative sample of patients assembled at a common (usually early) point in the course of their disease? Was the follow-up of the study patients sufficiently long and complete? Were objective outcome criteria applied in a blind fashion? If subgroups with different prognoses are identified, was there adjustment for important prognostic factors and validation in an independent test set patients?

2. 3. 4.

A.1. Was a defined, representative sample of patients assembled at a common (usually early) point in the course of their disease?

How well defined the individuals in the study criteria - representative of the underlying population.
inclusion, exclusion sampling method

similar, well-defined point in the course of their disease cohort

A.2. Was follow-up sufficiently long and complete? Ideal follow-up period Until EVERY patient recovers or has one of the other outcomes of interest, Until the elapsed time of observation is of clinical interest to clinicians or patients. Short follow up time too few study patients with outcome of interest little information of use to patient Loss to follow up influence the estimate of the risk of the outcome validity?. Patients are too ill (or too well); Die; Move, etc Most journals require at least 80% follow-up for a prognosis study to be considered valid. Best and worst case scenario!

A.3. Were objective outcome criteria applied in a blind fashion? investigators making judgments about clinical outcomes are kept blind to subjects clinical characteristics and prognostic factors. Minimize measurement bias!

Measurement bias
Measurement bias can be minimized by:
ensuring observers are blinded to the exposure status of the patients. using careful criteria (definitions) for all outcome events. apply equally rigorous efforts to ascertain all events in both exposure groups.

A.4. If subgroups with different prognoses are identified, was there adjustment for important prognostic factors and validation in an independent test set patients? Prognostic factors: factors associated with a particular outcome among disease subjects. Can predict good or bad outcome Need not necessarily cause the outcome, just be associated with them strongly enough to predict their development
examples includes age, co-morbidities, tumor size, severity of disease etc. often different from disease risk factors e.g., BMI and pre-menopausal breast CA.